Randomized phase III trial of a neoadjuvant regimen of four cycles of adriamycin plus cyclophosphamide followed by four cycles of docetaxel (AC4-D4) versus a shorter treatment of three cycles of FEC followed by three cycles of docetaxel (FEC3-D3) in node-positive breast cancer (Neo-Shorter; NCT02001506)
Abstract:Purpose
To determine whether six cycles of FEC3-D3 has a comparable efficacy to eight of AC4-D4.
Methods
The enrolled patients (pts) were clinically diagnosed with stage II or III breast cancer. The primary endpoint was a pathologic complete response (pCR), and the secondary endpoints were 3-year disease-free survival (3Y DFS), toxicities, and health-related quality of life (HRQoL).
Results
Among the 248 pts enrolled, one case was ineligible for screening; 10 discontinued treatment due to progressive dise… Show more
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